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Clinical Study of Double-Endoscopic Combined With Minimally Invasive Treatment for Early Gastric Cancer at Clinical Stage T1b

Clinical Study of Double-Endoscopic Combined With Minimally Invasive Treatment for Early Gastric Cancer at Clinical Stage T1b

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06934824
Enrollment
60
Registered
2025-04-18
Start date
2025-05-01
Completion date
2027-01-01
Last updated
2025-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy

Brief summary

For patients diagnosed with early gastric cancer involving submucosal invasion, super-ESD indications, or lymph node metastasis, a combination of preoperative endoscopic ultrasound and abdominal contrast-enhanced CT was utilized to ascertain the depth of tumor invasion and to identify any suspicious metastatic lymph nodes in the vicinity of the stomach. Subsequently, a local full-thickness resection, coupled with or followed by individualized precise lymph node dissection, was conducted to fulfill the following objectives: ① To investigate the safety, feasibility, and efficacy of local resection for patients meeting super-ESD criteria; ② To offer a clinical foundation for the individualized and precise lymph node dissection treatment of early gastric cancer.

Interventions

PROCEDURESixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und

Patients in group A-No lymph node metastasis, who underwent simple Double-Endoscopic Combined with local full-thickness resection. Patients in group B-imaging examination showed lymph node metastasis. patients were randomly divided into Group N + a and Group N + b. Group N + a: Local full-thickness gastric wall and lymph nodes dissection on D1 or D1 + were performed with Double-Endoscopic Group N + b: Traditional standard surgical gastrectomy and D1 or D1 + lymph nodes dissection was performed .

Sponsors

Hebei Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18-70 years old; 2. Endoscopic pathological diagnosis: adenocarcinoma; 3. Enhanced abdominal CT combined with endoscopic ultrasound clinical staging: T1bN0-1M0. 4. Has not received other treatment; 5. No other serious comorbidities; 6. Agree to participate in the study and sign the informed consent form.

Exclusion criteria

1. Pregnant or breastfeeding women 2. History of previous abdominal surgery 3. History of other previous malignancies 4. Can patients with severe heart, lung, brain diseases tolerate surgical treatment

Design outcomes

Primary

MeasureTime frame
Rate of recurrenceWithin 2 years

Secondary

MeasureTime frame
The operation time, complications and hospital stay were recorded30 days

Contacts

Primary ContactQun Zhao, Ph.D
zhaoqun@hebmu.edu.cnChina+8613930162111
Backup ContactGang pei Yang, Master's degree
China+8613731153070

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026